MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH CATAPULT, HYDROPHILLIC COATED INTRODUCER SHEATH SYSTEM, 6F, 45 CM, STRAIGHT

Model Number	FG-36045-001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The problem was described as: "catapult sheath fell apart upon insertion.Sheath was removed an alternate sheath was used.Patient is doing fine and customer is not upset." what is the next course of action? complaint and repair of this batch and others that are like it patient present at time of event? yes patient complications: no patient complications type of procedure: peripheral intervention as reported device codes: 1188: detachment of device or device component as reported patient codes: 9398: no clinical signs, symptoms or conditions device/procedure outcome: procedure completed, unable to use device - attempted, different device used (different model) patient outcome: f26: no health consequences or impact.
Additional Manufacturer Narrative
The root cause of the incident is unknown at time of the intitial report.The complaint device will not be returned for an evaluation.The dhr review, which examines the dhr, ncrs, and ecos was done as part of root cause investigation.
Additional Manufacturer Narrative
Initial report submitted on 03 july 2025, per mfr #: 3003637635-2025-00011.The complaint device was not returned.Therefore, testing of the actual device in the reported adverse event is not possible.The dhr/batch record review showed that there is no production or design issue that can lead to the defect which caused the complaint case.There is no process related root cause found from dhr review.Root cause is established as undeterminable.
Event or Problem Description
The problem was described as: "catapult sheath fell apart upon insertion.Sheath was removed an alternate sheath was used.Patient is doing fine and customer is not upset.".What is the next course of action? complaint and repair of this batch and others that are like it.Patient present at time of event? yes.Patient complications: no patient complications.Type of procedure: peripheral intervention.As reported device codes: 1188: detachment of device or device component.As reported patient codes: 9398: no clinical signs, symptoms or conditions.Device/procedure outcome: procedure completed, unable to use device - attempted, different device used (different model).Patient outcome: f26: no health consequences or impact.

• Brand Name: CATAPULT, HYDROPHILLIC COATED INTRODUCER SHEATH SYSTEM, 6F, 45 CM, STRAIGHT
• Common Device Name: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse. 37; dresden, 01277 ; GM 01277
• Manufacturer (Section G): CONTRACT MEDICAL INTERNATIONAL, SPOL. S R.O.; vazni 848; hradec kralove, 50003 ; EZ 50003
• Manufacturer Contact: juliana vaz neurnberger ; lauensteiner str. 37; GM 01277
• MDR Report Key: 22393159
• Report Number: 3003637635-2025-00011
• Device Sequence Number: 8930692
• Product Code: DYB
• UDI-Device Identifier: 04251244502096
• UDI-Public: 04251244502096
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K221914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FG-36045-001
• Device Catalogue Number: US-36045-F-ST-H
• Device Lot Number: 800682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown